A Prospective Pediatric Clinical Trial of Digital Music Players: Do They Interfere with Pacemakers?

Christine C. Chiu, M.Sc.; June Huh, M.D., Ph.D.; Laura De Souza, B.Sc.; Armando Alfaro-Ramirez, M.D.; Robin Clegg, M.D.; Laura Fenwick, B.Sc.; Robert M. Hamilton, M.D., M.H.Sc.; Joel A. Kirsh, M.D.; Gil J. Gross, M.D.; Dongsheng Gao, Ph.D.; Elizabeth A. Stephenson, M.D., M.Sc.

Disclosures

J Cardiovasc Electrophysiol. 2009;20(1):44-49. 

In This Article

Results

There were 67 patients who participated in the study, representing a 42% (67 of 161) recruitment rate. The mean age of the patients was 12 ± 5 years (median 14 years old, range 2-18 years). Sixty-two patients had pacemakers and five had ICDs; in total, 12 models of implanted devices from three different manufacturers ( Table 1 ) were represented. There were 39 endocardial and 28 epicardial systems. The programmed pacemaker modes and testing conditions are shown in Table 2 . Most patients were in a paced rhythm; only 19% (13/67) of patients were either not paced or intermittently paced during the study. All patients were tested with Sansa™ (n = 67) and the majority with iPod™ 30 GB (n = 51). Table 3 showed the other DMPs (n = 43), cellular telephones, and portable electronic games that were tested (n = 17). Tests were completed within 17 ± 6 minutes. There was no evidence of interference with pacemaker or ICD function by any DMP under any of the study conditions (each performed in triplicate) including testing in the worst case scenario of maximal sensitivity in unipolar configuration ( Table 2 ). We did not observe any detection in the high-rate counters related to the testing protocols conducted without the programmer wand. Any detections gathered in the artificially low high-rate counter (80 bpm) were examined and EGM/marker data were reviewed. The high-rate detections seen were consistent with the patient's normal rhythm and pacemaker function; no evidence of oversensing or EMI artifact was seen.

Reproducible programmer telemetry interference was shown in 11 of 67 (16%) patients (Programmer types: Medtronic, Minneapolis, MN, USA [6 of 47], St. Jude Medical, Sylmar, CA, USA [5 of 18], Boston Scientific/Guidant, Natick, MA, USA [0 of 2]) related to use of iPod™ (6), Sansa™ (1), or other DMP (4). In 4 of the 11 patients, more than one DMP used in testing could be shown to cause telemetry interference. Telemetry interference included loss of telemetry (3), artifacts on EGM (3), combined intermittent EGM noise, corrupted marker data, and loss of telemetry (5) (Figure 1). None of these were associated with any pacemaker malfunction as seen by continuous 6-lead ECG recording.

(A): Loss of telemetry was demonstrated in a patient with a Medtronic Kappa® VVIR pacemaker when the iPod™ was turned on and resumption of telemetry when the iPod™ was turned off. This was a reproducible behavior and occurred in all pacemaker sensing configurations that were tested (i.e., usual setting, maximal bipolar and unipolar configurations). Pacemaker function remained normal as evident by the ECG recording. The recorded channels are ECG lead II, markers, and ventricular EGM on the Carelink® 2090W programmer. (B): Intermittent artifacts on the EGM were shown in a patient with a St. Jude Medical Identity® VVIR pacemaker when the Sansa™ was turned on or off. This was a reproducible behavior and occurred in all pacemaker sensing configurations that were tested (i.e., usual setting, maximal bipolar and unipolar configurations). Appropriate pacemaker sensing and pacing function was shown as evidenced by the ECG recording. The recorded channels are ECG lead II, lead III, markers, and ventricular bipolar EGM on the Merlin™ PCS programmer. (C): There was combined intermittent loss of telemetry, artifacts on both EGM channels, and corrupted marker information in a patient with a St. Jude Medical Identity® DDD pacemaker when the iPod™ was in close proximity to the telemetry wand, turned on and turned off. Telemetry interferences were reproducible in all pacemaker sensing configurations that were tested (i.e., usual setting, maximal bipolar and unipolar configurations). Pacemaker function remained normal as evident by the ECG recording. The recorded channels are surface ECG, markers, bipolar atrial and ventricular EGM on the 3510P programmer.

Of note, all patient's personal electronics that were tested ( Table 3 ) yielded negative results with no evidence of interference with pacemaker function. In one instance, the patient's Sony Ericsson cellular telephone caused loss of telemetry when calls were made from the phone.

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